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Recall Observatory FDA recall evidence

Device product

Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.

Z-0699-2013

December 13, 2012

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 63958
Status
Terminated
Classification
Class II
Quantity
67,820 units
Official record key
device-enforcement:Z-0699-2013

Official wording

Reason: In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.

Code information: Lot Number/ Exp Date 2086315 February 20, 2013 2101435 February 20, 2013 2104316 February 27, 2013 2129460 February 27, 2013 2129487 March 13, 2013 2163211 February 27, 2013 2163213 March 20, 2013 2163215 March 27, 2013

Distribution pattern: Worldwide Distribution-USA including the states of MA, TN, KY, IN, GA, NC, TX, NY, FL, AZ, WA, NJ, MI, and CA, and the countries of Uruguay, Taiwan, Singapore, Australia, South Korea, Mexico, Hong Kong, Guatemala, Colombia, Chile, Canada, India, Japan, Brazil, China and Belgium.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.